510(k) · Cleared
ClearedSonosurg Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aomori Olympus Co., Ltd. · LFL Instrument, Ultrasonic Surgical
Cleared on Jan 25, 2005 as substantially equivalent to K000095 (The Olympus Optical Co., 2000) and 4 other predicates after a 168-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Jan 25, 2005
- Review
- 168 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K801623 (1980). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 3 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 2 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 1 generation backK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
- This deviceK042160 Sonosurg TrocarAomori Olympus Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −3 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −2 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −1 | K021962 | Olympus Ultrasonic Surgical System | The Olympus Optical Co. | 2003 | — |
| 0 (this device) | K042160 | Sonosurg Trocar | Aomori Olympus Co., Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000095 | Olympus Sonosurg Trocar XT3900 SystemSummary page 2…Product Device Name 510(k) # Manufacturer Class Code SonoSurg Trocar XT3900 #K000095 Olympus No Corporation. Classification Olympus SonoSurg System… | 2000 |
| * | K021962 | Olympus Ultrasonic Surgical SystemSummary page 2…Trocar XT3900 #K000095 Olympus No Corporation. Classification Olympus SonoSurg System #K021962 Olympus No #K031305 Corporation Classification LFL… | 2003 |
| * | K031305 | Olympus Ultrasonic Surgical SystemSummary page 2…Corporation. Classification Olympus SonoSurg System #K021962 Olympus No #K031305 Corporation Classification LFL #K031523 #K03171… | 2003 |
| * | K031523 | Olympus Ultrasonic Surgical SystemSummary page 2…System #K021962 Olympus No #K031305 Corporation Classification LFL #K031523 #K031710 D. SUMMARY DESCRIPTION OF THE DEVICE 1. Summary The SonoSurg Trocar is an Ultr… | 2003 |
| * | K031710 | Olympus Ultrasonic Surgical SystemSummary page 2…No #K031305 Corporation Classification LFL #K031523 #K031710 D. SUMMARY DESCRIPTION OF THE DEVICE 1. Summary The SonoSurg Trocar is an Ultrasonic trocar for endoscopic surgery which e… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 27 ancestors has a recall.
- 5 other devices also cite its predicate K000095.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall. This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for…
Read the full statement (154 words)
This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall.
This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for laparoscopic and general (open) surgery in intraabdominal and obstetric/gynecologic procedures, and endoscopic and general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures.
This instrument may also be combined with the SonoSurg Inigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system.
This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042160 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042160: Sonosurg Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042160
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026